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S0125, A Phase II Study Of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia (AML) In First Complete Remission (A BMT Study)

Phase 2
55 Years
69 Years
Not Enrolling

Thank you

Trial Information

S0125, A Phase II Study Of Chimerism-Mediated Immunotherapy (CMI) Using Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation In Older Patients With Acute Myeloid Leukemia (AML) In First Complete Remission (A BMT Study)

Primary objective:

- Determine whether allogeneic peripheral blood stem cell transplantation with
pre-conditioning low dose total body irradiation and fludarabine followed by
cyclosporine and mycophenolate mofetil, when given to elderly patients with acute
myeloid leukemia in first complete remission, is sufficiently efficacious (in terms of
survival 1 year after transplantation) to warrant a phase III investigation.

Secondary objective:

- Determine the frequency and severity of toxic effects of this regimen in these

Other objectives as funding permits:

- Determine whether chimerism patterns in bone marrow and blood after transplantation are
associated with relapse and/or graft-versus-host disease (GVHD) in these patients.

- Determine whether cytogenic, immunophenotypic, and molecular biologic features detected
in pre- and post-transplantation specimens are related to transplant outcomes and risk
of relapse in these patients.

OUTLINE: This is an open-label study.

- Conditioning regimen: Patients receive fludarabine IV over 1 hour on days -4 to -2.
Patients also undergo total body irradiation on day 0.

- Peripheral blood stem cell infusion (PBSC): Patients receive unmodified filgrastim
transplantation (G-CSF)-mobilized donor PBSC on day 0.

- Post-transplantation immunosuppression: Patients receive oral cyclosporine on days -3
to 35 followed by a taper until day 180. Patients also receive oral mycophenolate
mofetil on day 0 to 27 without tapering.

- Donor lymphocyte infusions (DLI): Patients with relapsed disease receive DLI IV over 30
minutes for up to 2 infusions.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually for 3 years.

PROJECTED ACCRUAL: A total of 25-51 patients will be accrued for this study.

Inclusion Criteria


- Morphologically confirmed acute myeloid leukemia (AML) (within 180 days of diagnosis)

- Secondary AML (secondary to myelodysplastic syndromes (MDS) or to prior leukemogenic

- Must have A1 marrow, B1 blood, and C1 extramedullary disease status

- Must have received prior remission induction chemotherapy

- Must have a genotypically HLA-identical sibling donor available that is not a
monozygotic identical twin

- No M3 AML or blastic transformation of chronic myelogenous leukemia

- If history of CNS leukemia, no leukemia cells in CNS by lumbar puncture within past 7

- Must be concurrently enrolled on protocols SWOG-9007 and SWOG-S9910



- 55 to 69

Performance status

- Zubrod 0-2

Life expectancy

- Not specified


- See Disease Characteristics


- Not specified


- Not specified


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No other malignancy within the past 2 years except for the following:

- Adequately treated basal cell or squamous cell skin cancer

- Carcinoma in situ of the cervix

- Adequately treated stage I or II cancer in complete remission


Biologic therapy

- No prior allogeneic hematopoietic stem cell transplantation


- See Disease Characteristics

- Prior consolidation therapy allowed

Endocrine therapy

- Not specified


- Not specified


- Prior organ transplantation allowed provided not concurrently receiving
immunosuppressive therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

measured from date of registration to study until death from any cause with patients still alive censored at date of last contact

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Peter McSweeney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rocky Mountain Cancer Centers - Denver Midtown


United States: Federal Government

Study ID:




Start Date:

April 2003

Completion Date:

June 2006

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia in remission
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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